双黄胶囊制剂工艺及其含量测定

Preparation technique and content determination of the Shuanghuang capsules

目的通过选择药物制剂适宜辅料与相应制粒方法,优选成型工艺;对胶囊制剂中主要活性成分大黄蒽醌、黄酮、多糖等进行含量测定,研究双黄胶囊制备工艺及其有效成分的含量分析。方法采用正交试验设计和控制变量法筛选药物制剂的辅料和制粒方法,并根据《中国药典》(2015年版)对制剂进行质量标准检查;采用高效液相色谱法对双黄胶囊进行有效成分含量测定。结果优选胶囊剂,设计方案为药物中间体∶稀释剂=1∶3,润湿剂为70%乙醇,用量为15%(15 ml/100 g药粉)。结论 HPLC可快速高效地测出双黄胶囊中各有效成分含量,有效地评价该制剂质量标准。

Objective To choose the appropriate materials and appropriate granulation process, preferably molding process for pharmaceutical preparations, and determine the content of active ingredients in the capsule formulation like anthraquinones, fla- vonoids, polysaccharides etc, to study preparation technique and content determination of the active ingredients in Shuanghuang capsules. Methods Use orthogonal design and control variables screening pharmaceutical formulation excipients and granulation process, and according to ＂People＇s Republic of China Pharmacopoeia＂ （2015 version） tested the quality of preparations; deter- minate the contents of the active ingredient by high performance liquid chromatography（HPLC）. Results The capsule was selected, and the design was drug intermediates： thinner = 1： 3, the wetting agent is 70 % ethanol, the amount of 15 % （ 15 mL / 100 g powder）. Conclusion Each active ingredient content in the double yellow capsules can be measured by HPLC well and evaluate the quality standards of preparation effectively.